Deroyal Industries, Inc. Lafollette
FDA Regulatory Profile
Summary
- Total Recalls
- 12 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2499-2021 | Class I | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set | September 2, 2021 |
| Z-1483-2020 | Class II | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardia | February 6, 2020 |
| Z-1414-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy | February 4, 2020 |
| Z-1415-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparos | February 4, 2020 |
| Z-1416-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid | February 4, 2020 |
| Z-1412-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pa | February 4, 2020 |
| Z-1413-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General | February 4, 2020 |
| Z-1418-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit | February 4, 2020 |
| Z-1419-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular | February 4, 2020 |
| Z-1417-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmolo | February 4, 2020 |
| Z-1410-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient | February 4, 2020 |
| Z-1411-2020 | Class II | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear | February 4, 2020 |